Phase 1 dose escalation trial of monotherapy IDE574 expected to begin in 1Q 2026
Targeting to present preclinical data detailing pharmacologic profile and evidence of anti-tumor activity in solid tumor models at a medical conference in 1H 2026 SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, announced the submission of an investigational new drug (IND) application... Read more
Olanzapine long-acting injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation, for a broad patient population1
Olanzapine LAI is designed to help support real-world adherence and improved stability, with the goal of addressing a critical treatment gap for people living with schizophrenia1
Teva is committed to advancing this innovative treatment option and further build on its differentiated LAI franchise... Read more
Submission based on positive BaxHTN Phase III trial results which demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension
If approved, baxdrostat could be the first aldosterone synthase inhibitor to receive regulatory authorization WILMINGTON, Del. / Dec 02, 2025 / Business Wire / AstraZeneca’s New Drug Application (NDA) for baxdrostat has been accepted for Priority... Read more
sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025
First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA
Primary and key secondary endpoints met with high statistical significance (p <0.0001)
Favorable recurrence outcomes at one-year follow-up
BCC is the most common skin cancer in the US with more than 3 million cases diagnosed annually1 WOBURN, Mass., Dec. 02,... Read more
FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026.
NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine.
Current worldwide generic... Read more
If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds
Would potentially provide a cost-effective and convenient option to address episodes of fluid buildup at home, benefiting patients, providers and payors
PDUFA target action date of July 26, 2026 WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced... Read more
B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively
Deep and durable regressions observed with IDE034 monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression
Enhanced durability with IDE034 and IDE161 PARG inhibitor combination in preclinical in vivo models; targeting to share additional preclinical data supporting mechanistic... Read more
CAMBRIDGE, Mass., Nov. 24, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed the review of the Investigational New Drug (IND) amendment application and authorized the Company to initiate the pivotal Phase 3 clinical trial for the evaluation of... Read more
PRINCETON, N.J. and TOKYO and CAMBRIDGE, Mass., Nov. 20, 2025 /PRNewswire/ -- Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced the companies have initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the treatment of patients... Read more
NDA based on data from global ARROS-1 Phase 1/2 clinical trial
FDA assigns PDUFA target action date of September 18, 2026 CAMBRIDGE, Mass., Nov. 19, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for... Read more
MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the completion of the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), advanced breast cancer (“ABC”).... Read more
Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026
If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2 WESTLAKE VILLAGE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA acceptance... Read more
Northvale, New Jersey--(Newsfile Corp. - November 12, 2025) - Elite Pharmaceuticals, Inc. (OTCBB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP), with strengths of 2 mg, 4 mg, 6 mg, 8 mg, and... Read more
Key Points Immuron receives U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application and clinical study may proceed
FDA assigned an IND number (032095) for the IMM-529 application
IND 32095 is Immuron’s Investigational new drug (IND) application for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI) and is now active MELBOURNE, Australia, Nov. 05,... Read more
Company’s first metered-dose inhalation (MDI) product and establishes a new growth vector for the Affordable Medicines segment BRIDGEWATER, N.J., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has tentatively approved the Company’s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol (40 mcg/actuation and... Read more
PDUFA Date Set for August 13, 2026 BEDFORD, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MK-6240, the company’s investigational F18-labeled tau-targeted... Read more
BRISBANE, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients today reported it has received a Paragraph IV Certification Notice Letter (PIV Notice) from The WhiteOak Group, a subsidiary of a small private Chinese company. WhiteOak has filed an Abbreviated New Drug Application, or ANDA, with the FDA for a product claiming... Read more
Epioxa Provides the Ophthalmic Community and Patients with the First and Only FDA-Approved, Incision-Free, Topical Drug Therapy for Keratoconus
Epioxa Represents a Novel, Groundbreaking Therapy for Patients Afflicted by This Sight-Threatening Rare Disease
Epioxa Expected to Be Commercially Available in Q1 2026 ALISO VIEJO, Calif. / Oct 20, 2025 / Business Wire / Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on... Read more
Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration
NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS CITY, Kan., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform,... Read more
Key Points Immuron submits Investigational new drug (IND) application to FDA for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI)
Previous clinical trial data on IMM-529 provides support for continued development of IMM-529 MELBOURNE, Australia, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is pleased to announce that it has submitted an Investigational New Drug (IND)... Read more
The DECLARATION (safety and efficacy vs. placebo) and LIBERTY (exploratory safety head-to-head and combination with mRNA-based COVID vaccination) clinical trials are expected to begin around year-end 2025; top-line data anticipated mid-2026
DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate prevention of COVID, at three months, from a single intramuscular (IM) dose of VYD2311, with longer-term protection anticipated. A second VYD2311... Read more
Disc is seeking accelerated approval and priority review of its NDA submission
FDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the submission of... Read more
KETAFREE™ to provide innovative, preservative-free IV ketamine formulation, eliminating toxic preservatives, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugs
Filing is based on FDA interaction and approval of Suitability Petition for NRx’s proposed strength of preservative-free ketamine
This presentation of ketamine represents a reshoring of a strategically important drug to the US, in keeping with the Presidential Executive... Read more
RAPT on track to initiate trial this year SOUTH SAN FRANCISCO, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared RAPT’s Investigational New Drug (IND) Application... Read more
Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum
Positive results across all three Phase 3 TEMPO trials reinforce the potential of tavapadon, a novel selective dopamine D1/D5 receptor partial agonist, in Parkinson's disease
If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option NORTH... Read more
Calgary, Alberta--(Newsfile Corp. - September 23, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to no-option individuals suffering from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, in Florida under Florida's SB 1768, is pleased... Read more
Regulatory submissions filed in the U.S., UK, Europe, Serbia and Australia
Three-month randomized placebo-controlled study to assess safety, pharmacokinetics, dose, muscle biopsies, and measures of function in ambulatory children
First patient expected to be enrolled into the study by the end of 2025
Long-term extension study approved in Australia with adult patients from the Phase 1b trial; additional adult patients also planned
Company also provides financial update... Read more
FDA assigns a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 REDWOOD CITY, Calif. / Sep 10, 2025 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the U.S. Food and Drug Administration (FDA) has accepted Corcept’s... Read more
There are currently no approved vaccines or treatments for norovirus infection
Cocrystal’s CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections
Phase 1b study is expected to start by year-end 2025 BOTHELL, Wash., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the Company received a Study May Proceed Letter... Read more
If approved, ZORYVE cream would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2, offering patients and caregivers an important alternative to topical steroids and vitamin-D analogs
ZORYVE cream is uniquely formulated to be effective, safe, and well tolerated for all areas of the body, including sensitive areas such as intertriginous skin, where plaque psoriasis often presents in children WESTLAKE VILLAGE, Calif.,... Read more
